What is the Origin of New Drug Approval?

The concept of formal drug approval originated from landmark legislation, such as the 1938 Federal Food, Drug, and Cosmetic Act in the US, which mandated that new drugs must be proven safe before marketing. This requirement was later strengthened to include proof of efficacy, establishing the modern regulatory pathway. The NDA process is the culmination of decades of public health policy development.

What is the Mechanism of New Drug Approval?

The mechanism of the NDA involves a systematic review by regulatory scientists and clinicians who evaluate the submitted evidence, including all clinical trial phases and manufacturing chemistry. The review assesses the drug's risk-benefit profile for the intended population and indication. Approval is granted only when the data convincingly demonstrate that the therapeutic benefits outweigh the potential risks, ensuring public health protection.

New Drug Approval ∞ Area

New Drug Approval

Meaning

New Drug Approval (NDA) is the formal regulatory process by which a governmental agency, such as the U.S. Food and Drug Administration (FDA), authorizes a pharmaceutical company to market and sell a new drug product in their jurisdiction. This extensive process requires the submission of comprehensive data from preclinical studies, clinical trials, and manufacturing controls to demonstrate the drug’s safety, efficacy, and quality. Achieving NDA status signifies that the compound has met the rigorous scientific and legal standards for public use.